Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients in Low Disease Activity or Remission.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 17
- 主要终点
- proportion of patients who could withdraw from prednisone and hydrocortisone at one year
研究概览
简要总结
The purpose of this study is to compare the proportion of patients who could withdraw from prednisone and hydrocortisone one year after a progressive decrease of GC (GC tapering) or a hydrocortisone replacement therapy in rheumatoid arthritis in remission or low disease activity.
详细描述
French multicenter double-blind controlled parallel-group randomized clinical trial Phase IV assessing whether a hydrocortisone replacement therapy could increase the success rate of GC withdrawal at one year, in patients with Rheumatoid Arthritis in low disease activity or remission, in comparison to progressive decrease of GC (GC tapering).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years old.
- •Fulfilling the 2010 American College of Rheumatology (ACR)/EULAR criteria for RA.
- •Treated with a stable dose of Synthetic Disease Modifying Anti-Rheumatic Drugs (sDMARD) or Biological Disease Modifying Anti-Rheumatic Drug (bDMARD) for at least 3 months.
- •Who have been treated with prednisone or prednisolone for at least 6 months.
- •With a stable dose of prednisone or prednisolone of 5mg/day for at least 3 months.
- •With a DAS28 ≤3.2 for at least 3 months.
- •Patients with health insurance
- •Patients who have signed a written informed consent form.
排除标准
- •Any chronic condition that would need long term corticoid use (e.g. chronic lung diseases).
- •Evidence of a flare within the last 3 months.
- •Evidence of an allergy or intolerance to hydrocortisone or prednisone.
- •Chronic idiopathic, or autoimmune clinical adrenal insufficiency.
- •GC joint injections within the last 3 months or scheduled in the next 3 months.
- •Any GC intake expected more than >5mg/day within the next 12 months.
- •Association with sultopride and with live vaccines
- •Significant trauma or major surgery within the 3 months prior to the baseline visit.
- •Scheduled surgery in the next 12 months.
- •Fibromyalgia.
- •Foreseeable poor compliance with the strategy.
- •Patient with any condition that would prevent participation in the study and completion of the study procedures, including language limitation.
- •Alcohol and/or drug misuse as determined by the investigator.
- •Pregnancy or breastfeeding.
- •Patient is not willing to sign the informed consent.
- •Juridical Protection
- •DAS28>3.2 after one month of a stable dose of prednisone 5 mg/day.
研究组 & 干预措施
Glucocorticoid (GC) tapering
"GC tapering group": patients will be asked to taper prednisone taken every morning at 8.00 AM by decreasing the daily dose by 1 mg every month as soon as they are in remission or Low Disease Activity (LDA). In addition they will receive a placebo of 20 mg/day of hydrocortisone (10 mg at 8.00 AM, 10 mg at 12.00 AM) for 3 months then 10 mg/day (at 8.00 AM) of hydrocortisone placebo for 3 months before discontinuing the hydrocortisone placebo.
干预措施: GlucoCorticoid (Drug)
Hydrocortisone replacer
"Hydrocortisone replacer group": patients will replace prednisone with 20 mg of hydrocortisone on a daily basis (10 mg at 8.00 AM, 10 mg at 12.00 AM) for 3 months then 10 mg daily (at 8.00 AM) for 3 months then stop as soon as they are in remission or LDA, as well as a prednisone placebo (at 8.00 AM) with a schedule to taper the prednisone placebo by 1mg/day every month until discontinuation.
干预措施: GlucoCorticoid (Drug)
结局指标
主要结局
proportion of patients who could withdraw from prednisone and hydrocortisone at one year
时间窗: one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement
To compare a prednisone tapering strategy to a hydrocortisone replacement strategy on the success rate of prednisone and hydrocortisone withdrawal at one year in Rheumatoid Arthritis patients in low disease activity or remission.
次要结局
- proportion of patients who have at least one flare confirmed by the investigator during the protocol.(one year)
- proportion of patients in DAS28 remission and in DAS28 low disease activity(7 and 12 months)
- proportion of patients needing extra prednisone to control flares(one year)
- area under the curve of means of the FLARE (Flare Assessment in Rheumatoid Arthritis)(one year)
- medians of Health Assessment Questionnaire (HAQ)(4, 7 months and 1 year)
- medians of EuroQol 5-dimensional Descriptive system (EQ-5D)(4, 7 months and 1 year)
- medians of Functional Assessment of Chronic Illness Therapy - Fatigue Scale FACIT-F)(4, 7 months and 1 year)
- proportion of patients with Serious Adverse events(1 year)
- proportion of patients who could withdraw from prednisone(one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement)
- proportion of patients with acute adrenal insufficiency(one year)
- proportion of patients with biological adrenal insufficiency(one year)
- medians of Rheumatoid Arthritis Impact of Disease (RAID)(4, 7 months and 1 year)